Bristol-Myers Squibb’s daclatasvir and Gilead Sciences’ Sovaldi (sofosbuvir), plus ribavirin, cured high rates of hepatitis C virus (HCV) among those with advanced cirrhosis or liver transplantees with recurring virus in a recent trial. The major exception was people with very advanced cirrhosis, only half of whom were cured. Researchers from the Phase III ALLY-1 study, in which 12 weeks of the regimen was given to treatment-naive or treatment-experienced people with genotypes 1, 2, 3, 4 and 6, presented their findings at the 50th International Liver Congress in Vienna, Austria.

The participants were divided into two groups: 60 people with cirrhosis and 53 who had a transplanted liver. Of the cirrhotic group, 40 percent of participants were treatment naïve, and 75 percent had HCV genotype 1. Of the transplantees, 42 percent were treatment-naïve and 77 percent had genotype 1. All the participants with cirrhosis who received a liver transplant while on treatment could receive 12 weeks of extended treatment immediately after the operation.

Among those in the cirrhosis group, 83 percent (50 of 60) achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). Seventy-six percent (26 of 34) of those with genotype 1a were cured, as were 100 percent (11 of 11) of those with genotype 1b, 83 percent (5 of 6) of those with genotype 3, and 89 percent (8 of 9) of those with genotypes 2, 4 or 6. Breaking down the results of people with genotype 1 by their cirrhosis progression, 91 percent (10 of 11) of those with Child-Pugh class A were cured, as were 92 percent (22 of 24) of those with class B, and just 50 percent (5 of 10) of those with class C.

Among the post-transplant group, 94 percent (50 of 53) were cured, including 97 percent (30 of 31) of those with genotype 1a, 90 percent (9 of 10) of those with genotype 1b, 91 percent (10 of 11) of those with genotype 3, and 100 percent (1 of 1) of those with the remaining genotypes.

Four people with cirrhosis received a liver transplant during the study, three of whom extended their treatment. All four were cured.

The most common side effects of the regimen were headache, fatigue, anemia, diarrhea and nausea. There were no treatment-related serious side effects. One of the transplantees stopped treatment after a month because of headache but was still cured.

To read the press release and abstract, click here.